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Post by Deleted on Apr 20, 2015 15:15:01 GMT -5
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Post by notamnkdmillionaire on Apr 20, 2015 15:27:47 GMT -5
I don't think it means much. If there was something substantial to it, it would have been revealed by now,imo.
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Post by bradleysbest on Apr 20, 2015 15:28:17 GMT -5
My best guess is the 12U cartridge has been approved & a better label for Afrezza will be announced soon!
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Post by Deleted on Apr 20, 2015 15:31:36 GMT -5
My best guess is the 12U cartridge has been approved & a better label for Afrezza will be announced soon! better label requires study/trials.. so i dont think so.. It could only be related to 12U or additional lines |
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Post by bradleysbest on Apr 20, 2015 15:34:14 GMT -5
Can't they use trials from other countries?
PS...i will gladly take additional lines!
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Post by tripoley on Apr 20, 2015 15:35:08 GMT -5
Interesting. Approval was 000. The label revision 005 was for “Replacement Inhaler- Not for Sale”. 003 was approved on 04/17/2015 for an unknown reason. The 12 unit cartridge was either 001, 002 or 004. That leaves two for?
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Post by Deleted on Apr 20, 2015 15:37:59 GMT -5
Interesting. Approval was 000. The label revision 005 was for “Replacement Inhaler- Not for Sale”. 003 was approved on 04/17/2015 for an unknown reason. The 12 unit cartridge was either 001, 002 or 004. That leaves two for? Line 2 approval Line 3 approval |
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Post by james on Apr 20, 2015 15:40:48 GMT -5
Completion of the additional lines is a possibility, but it seems early for that. I'm also not sure that the information would show up on a tracking site about labeling.
I expect that adding the 12U cartridge would require relabeling if nothing else. The current label clearly shows a 4U (blue cartridge) and 8U (green cartridge) option; no 12U to be found.
I don't have any good idea for what this is - some minor adjustment in packaging?
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Post by tripoley on Apr 20, 2015 15:44:35 GMT -5
Interesting. Approval was 000. The label revision 005 was for “Replacement Inhaler- Not for Sale”. 003 was approved on 04/17/2015 for an unknown reason. The 12 unit cartridge was either 001, 002 or 004. That leaves two for? Line 2 approval Line 3 approval 003 could be for line 2 or 3 approval as well. That wouldn't require a label change. "Manufacturing Change or Addition." And why couldn't both lines be for one NDA? |
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Post by otherottawaguy on Apr 20, 2015 15:44:41 GMT -5
Started this in its own topic, moved here to consolidate:
Item Code NDC11 Proprietary Name Dosage Form Marketing Category Application Number or Citation Product Type Marketing Start Date Marketing End Date Billing Unit
47918-004-02 47918000402 Afrezza POWDER, METERED NDA NDA022472 HUMAN PRESCRIPTION DRUG 20140711 20141022
47918-004-03 47918000403 Afrezza POWDER, METERED NDA NDA022472 HUMAN PRESCRIPTION DRUG 20140711 20141022
47918-008-03 47918000803 Afrezza POWDER, METERED NDA NDA022472 HUMAN PRESCRIPTION DRUG 20140711 20141022
47918-048-21 47918004821 Afrezza KIT NDA NDA022472 HUMAN PRESCRIPTION DRUG 20140711 20141022
47918-084-21 47918008421 Afrezza KIT NDA NDA022472 HUMAN PRESCRIPTION DRUG 20140711 20141022
47918-840-33 47918084033 Afrezza KIT NDA NDA022472 HUMAN PRESCRIPTION DRUG 20140711 20141022
0024-5874-90 24587490 Afrezza POWDER, METERED NDA NDA022472 HUMAN PRESCRIPTION DRUG 20140711 EA
0024-5882-36 24588236 Afrezza KIT NDA NDA022472 HUMAN PRESCRIPTION DRUG 20140711 EA
0024-5884-63 24588463 Afrezza KIT NDA NDA022472 HUMAN PRESCRIPTION DRUG 20140711 EA
I see 3 sets of Powder and Kit that are in sequence:
NDC 47918-004-02, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 60 - 4 unit cartridges and 2 inhalers
NDC 47918-004-03, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 90 - 4 unit cartridges and 2 inhalers
NDC 47918-008-03, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 90 - 8 unit cartridges and 2 inhalers
NDC 47918-048-12, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 90 cartridges; 60 – 4 unit cartridges and 30 - 8 unit cartridges and 2 inhalers
NDC 47918-048-21, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 90 cartridges; 30 – 4 unit cartridges and 60 - 8 unit cartridges and 2 inhalers
NDC 47918-048-33, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 180 cartridges; 90 - 4 unit cartridges and 90 – 8 unit cartridges and 2 inhalers
its the last three that have no end date and have out of sequence reference numbers that I am interested in:
0024-5874-90 - 90 POWDER, METERED in 1 PACKAGE (0024-5874-90)
0024-5882-36 - 90 PACKAGE in 1 CARTON (0024-5882-36) > 1 KIT in 1 PACKAGE * 60 POWDER, METERED in 1 BLISTER PACK * 30 POWDER, METERED in 1 BLISTER PACK
0024-5884-63 - 90 PACKAGE in 1 CARTON (0024-5884-63) > 1 KIT in 1 PACKAGE * 60 POWDER, METERED in 1 BLISTER PACK * 30 POWDER, METERED in 1 PACKAGE
Anyone care to speculate on the last three?
Link: CSV "Item Code",NDC11,"Proprietary Name","Dosage Form" ... For Industry
2015-04-17 | www.fda.gov/downloads/forindustry/datastandards/structuredproductlabeling/ucm363569.csv
... 47918-004-02,47918000402,Afrezza,"POWDER, METERED",NDA,NDA022472," HUMAN PRESCRIPTION DRUG",20140711,20141022,. ...
OOG
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Post by liane on Apr 20, 2015 15:55:18 GMT -5
OOG,
Do you have a link so we can see this in context? Do the last 3 items even refer to Afrezza?
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Post by tripoley on Apr 20, 2015 16:10:47 GMT -5
004 is 4 unit, 008 is 8 unit, and 048 is a combination of 4 and 8 units. 02 is 60, 03 is 90, 12 is 30 of one size and 60 of the other, 21 is 60 of one size and 30 of the other and 33 is 90 of both sizes. 12 and 21 seem backwards according to their nomenclature by the wording. 90 is 90 of one size, 36 is 30 of one size and 60 of the other and 63 is 60 of one size and 30 of the other. Again, nomenclature seems odd on 36 by the wording but okay on 63. So is 0024 a 2 unit and 4 unit but why not 024? I could see the 12 unit being 0012.
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Post by liane on Apr 20, 2015 16:12:57 GMT -5
So I do see it is Afrezza. The only difference I see between those 3 and the ones listed above is that the 3 make no mention of an inhaler. Maybe in something like a hospital setting you would want them separate?
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Post by spiro on Apr 20, 2015 16:33:57 GMT -5
Ok, here is Spiro's .02 worth, you guys are a bunch of cartridge nerds.
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Post by mnholdem on Apr 20, 2015 17:24:44 GMT -5
Could those be various sample packs?
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